FDA 510(k) Application Details - K193020

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K193020
Device Name	Sleeve, Limb, Compressible
Applicant	Innovamed Health, LLC 270 West 500 North North Salt Lake, UT 84054 US Other 510(k) Applications for this Company
Contact	Luke Zeutzius Other 510(k) Applications for this Contact
Regulation Number	870.5800   More FDA Info for this Regulation Number
Classification Product Code	JOW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2019
Decision Date	12/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review